Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy

November 5, 2019 updated by: University Hospital, Basel, Switzerland

Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.

Study Overview

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Basel, Switzerland, 4031
        • Klinik für Herzchirurgie, Universitätsspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with mitral valve reconstruction done via minimal invasive antero- lateral thoracotomy (2009-2018) at Universitätsspital Basel.

Description

Inclusion Criteria:

  • Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Exclusion Criteria:

  • Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HTK-Bretschneider cardioplegic solution
Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution
cardioplegia with HTK-Bretschneider cardioplegic solution
St. Thomas cardioplegic solution
Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution
cardioplegia with St. Thomas cardioplegic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
high specific troponin T (hs-TrT) (μg/l)
Time Frame: perioperative during minimal invasive surgery
cardial biomarker for myocardial damage
perioperative during minimal invasive surgery
Creatin-Phosphokinase (CK) (U/l)
Time Frame: perioperative during minimal invasive surgery
cardial biomarker for myocardial damage
perioperative during minimal invasive surgery
Creatinkinase Muscle- Brain (CK-MB) (U/l)
Time Frame: perioperative during minimal invasive surgery
cardial biomarker for myocardial damage
perioperative during minimal invasive surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rate
Time Frame: from minimal invasive surgery until 30 days post surgery
number of deaths
from minimal invasive surgery until 30 days post surgery
length of stay in intensive care unit (days)
Time Frame: from minimal invasive surgery until 30 days post surgery
length of stay in intensive care unit (number of days)
from minimal invasive surgery until 30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Martin Grapow, Prof. Dr., Klinik für Herzchirurgie, Universitätsspital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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